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FDA 510(k)

OmniTrans Transport System

K-Number: K240235 · 2024-08-19

ApplicantShenzhen Dakewe Bio-Engineering Co., Ltd.
Decision Date2024-08-19
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OmniTrans Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. It received FDA 510(k) clearance on 2024-08-19 under 510(k) number K240235. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OmniTrans Transport System?

OmniTrans Transport System is a medical device that received FDA 510(k) clearance on 2024-08-19. The listed applicant is Shenzhen Dakewe Bio-Engineering Co., Ltd.. The 510(k) number is K240235.

When did OmniTrans Transport System receive FDA 510(k) clearance?

OmniTrans Transport System received FDA 510(k) clearance on 2024-08-19, under 510(k) number K240235.

Who is the listed applicant for OmniTrans Transport System?

The FDA 510(k) record lists Shenzhen Dakewe Bio-Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmniTrans Transport System?

The FDA product code for OmniTrans Transport System is JSM.

Other records listing Shenzhen Dakewe Bio-Engineering Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230035BioSci™ Disposable Virus Sampling TubesK220059Biosci™ Inactivated Transport Medium, Biosci™ ITM

Related Devices (Code: JSM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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